CTNF 18/528,035 CTNF 85046 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. DETAILED ACTION Election/Restrictions Applicant’s election without traverse of group I, claims 1-9, Fig. 3 in the reply filed on 05/13/2026 is acknowledged. Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Thus, claims 1-9 are presently pending in this application. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 1-2 and 6-9 are rejected under 35 U.S.C. 102( a)(1) and 102 (a)(2 ) as being anticipated by Morin et al. (2018/0055631) “Morin” . Regarding claim 1, Morin discloses an implantable medical device 302 (Fig. 3A) adapted to be implanted at an implantation site (abstract), the implantable medical device 302 comprising: an expandable frame that is adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment (abstract and par. 0045 discloses stent frame); one or more valve cusps secured relative to the expandable frame (as shown in Fig. 3B, prosthetic heart valve is attached to stent frame 302; par. 0054); an inner skirt 306 surrounding a portion of the expandable frame (par. 0052 and Fig. 3A disclose cuff 306 is inner cuff attached to the inner/luminal surface of the stent frame); and an outer skirt 350 surrounding a portion of the expandable frame (par. 0052 and Fig. 3A disclose the outer cuff 350 is attached to stent frame at distal edge 358), the outer skirt attached to the expandable frame via one or more sutures that axially secure the outer skirt relative to the expandable frame yet allow the outer skirt to move radially relative to the expandable frame (par. 0052 discloses the outer skirt 350 is secured to the stent frame 302 at distal edge 358 with sutures located at attachment points S1 which allow for the outer skirt to billow outwardly in response to retrograde blood flow). Regarding claim 2, Morin discloses wherein the expandable frame 302 comprises: an upper crown portion (portion of annulus section 340 above edge 358 Fig. 3A); a lower crown portion (portion of annulus section 340 below edge 358; Fig. 3A); commissural posts 316 extending proximally from upper crown portion (as shown in Fig. 3A); and stabilization arches extending proximally from commissural posts (the struts extending from posts 316 on the opposing end as the cuff 350 are arches as shown in Fig. 10B). Regarding claim 6, Morin discloses wherein: a distal edge 352 of the outer skirt 350 is sewn relative to the inner skirt 306 (par. 0052); and a proximal edge 358 of the outer skirt overlies at least a portion of the upper crown portion (as shown in Fig. 3A the outer skirt 350 has an edge 358 attached at and overlies the upper crown portion). Regarding claim 7, Morin discloses wherein each of the one or more sutures are adapted to allow the proximal edge 358 of the outer skirt 350 to billow outwards in response to fluid pressure on the outer skirt (par. 0052 discloses the outer skirt 350 is secured to the stent frame 302 at distal edge 358 with sutures located at attachment points S1 which allow for the outer skirt to billow outwardly in response to retrograde blood flow). Regarding claim 8, Morin discloses wherein both ends of each of the one or more sutures attach to the outer skirt at a single position (par. 0052 discloses a continuous line of suture attached at distinct attachment points S1). Regarding claim 9, Morin discloses wherein for each of the one or more sutures, a first end of a suture attaches to the outer skirt at a first position and a second end of the suture attaches to the outer skirt at a second position circumferentially spaced from the first position (par. 0052 discloses a continuous line of suture attached at distinct attachment points S1 that are spaced apart in a circumferential direction) . Claim Rejections - 35 USC § 103 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-21-aia AIA Claim s 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Morin et al. (2018/0055631) “Morin” in view of Alkhatib et al. (2014/0005775) “Alkhatib” . Morin discloses the claimed invention of claims 1 and 2; except for wherein each of the one or more sutures are secured relative to one of the commissural posts; wherein each of the one or more sutures extend beyond the corresponding commissural posts and loop around a base of the stabilization arches above the corresponding commissural posts and wherein each of the sutures are enveloped within the valve cusps secured relative to each of the commissural posts. However, Alkhatib teaches a similar medical device comprising each of the one or more sutures S (par. 0048 and Fig. 6C) are secured relative to one of the commissural posts 500 (Fig. 6C); wherein each of the one or more sutures extend beyond the corresponding commissural posts 500 and loop around a base of stabilization arches 514a/b (Fig. 6C and par. 0048) above the corresponding commissural posts (as shown in Fig. 6C, the suture S loops around p10/11 and p5/6) and wherein each of the sutures are enveloped within the valve cusps 850 secured relative to each of the commissural posts 500 (as shown in Figs. 6A-6B; par. 0044). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical device in Morin to include each of the one or more sutures are secured relative to one of the commissural posts; wherein each of the one or more sutures extend beyond the corresponding commissural posts and loop around a base of the stabilization arches above the corresponding commissural posts and wherein each of the sutures are enveloped within the valve cusps secured relative to each of the commissural posts, as taught and suggested by Alkhatib, for adequately securing the leaflets to the stent without adding unwanted bulk to the leaflet-commissure junction (par. 0006). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT). If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /YASHITA SHARMA/ Primary Examiner, Art Unit 3774 Application/Control Number: 18/528,035 Page 2 Art Unit: 3774 Application/Control Number: 18/528,035 Page 3 Art Unit: 3774 Application/Control Number: 18/528,035 Page 4 Art Unit: 3774 Application/Control Number: 18/528,035 Page 5 Art Unit: 3774
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